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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02560896
Other study ID # 15-001209
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2015
Est. completion date November 4, 2019

Study information

Verified date June 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Currently, there is no clear legal or ethical guidance about how researchers and IRBs ought to proceed when the research participant in a biobank is deceased and there is clinically relevant information that could be disclosed to family members. This study is designed to test a procedure offering genetic information to family members of research participants who participated in a pancreatic cancer biobank in a Health Insurance Portability and Accountability Act (HIPAA) -compliant design.


Description:

To develop, prototype, and evaluate a novel procedure for offering probands' genetic results to family members. The intervention is to offer a deceased research participant's actionable germline genetic research finding, and depending upon the choice made by the next of kin, a disclosure of the research finding by a genetic counselor in a family conference call. Using mixed methods (quantitative and qualitative), the investigators will assess decision making, family communication, and actions and responses in individuals from families in which a proband is known to have a deleterious germline mutation in one of several known cancer susceptibility genes.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date November 4, 2019
Est. primary completion date November 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Family members and others authorized to receive health information of participants enrolled under Institutional Review Board (IRB) #354-06 and #355-06 who carry one of several known cancer susceptibility genes. - Mentally competent and able to provide informed consent - Able to understand and read English

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (3)

Lead Sponsor Collaborator
Mayo Clinic University of California, San Francisco, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Uptake of disclosure invitation The primary outcome is: relative proportions of individuals who, when offered genetic results of a deceased family member who participated in a biobank study, will decide to learn those results. Uptake will be a binary outcome (Yes/No). We will enumerate the number of invited participants who choose to learn results and who choose not to learn results. 6 months
Secondary Frequency and duration of physical activity We will measure and compare changes between baseline and 6 months following genetic test disclosure: number of self-reported days per week and exercise duration(minutes). 6 months
Secondary Frequency and duration of alcohol use We will measure and compare changes between baseline and 6 months following genetic test disclosure: number of drinks containing alcohol taken per week over previous six months; frequency drinking 6 or more drinks in one occasion in past 6 months (Never; Less than monthly; Monthly; 2 to 3 times per week; 4 or more times per week) 6 months
Secondary Current cigarette smoking status We will measure and compare changes between baseline and 6 months following genetic test disclosure: Current cigarette smoker (Yes/No) 6 months
Secondary Quality and amount of sleep We will measure and compare changes between baseline and 6 months following genetic test disclosure: Quality of sleep (Very good; Fairly good; Fairly bad; Very bad); Number of hours of sleep in a 24 hour period (hours and minutes) 6 months
Secondary Frequency of fruit and vegetable consumption We will measure and compare changes between baseline and 6 months following genetic test disclosure: Number of servings eaten in a typical day (None; 1 or less; 2; 3; 4; 5 or more) 6 months
Secondary Frequency of red meat consumption We will measure and compare changes between baseline and 6 months following genetic test disclosure: Number of times consumed per typical week (0; 1 to 5; 6 to 10; 11 to 15; 16 to 20; 21 or more). 6 months
Secondary Uptake of genetic testing The relative proportion of individuals who request and obtain genetic testing on their own by 6 months 6 months
Secondary Quality of life Changes in self-reported quality of life on a scale of 0(a bad as it can be) to 10 (as good as it can be) 6 months
Secondary Perceived cancer risk/worry Changes in self-reported worry of developing cancer on a scale of 1 (not at all or rarely to 4 (almost all the time) 6 months
Secondary Decision regret Self-reported rating of regret to learn/not learn their relative's genetic research result using a 5-item scale rating (Strongly agree to Strongly disagree). 6 months
See also
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Active, not recruiting NCT04247503 - Cohort Study of Pancreatic Cancer Risk
Recruiting NCT04743479 - Artificial Intelligence-based Early Screening of Pancreatic Cancer and High Risk Tracing (ESPRIT-AI)
Recruiting NCT04095195 - Registry of Subjects at Risk of Pancreatic Cancer
Recruiting NCT00835133 - Collecting Blood and Tissue Samples From Family Members of Patients With Pancreatic Diseases, Pancreatic Cancer, and Melanoma
Active, not recruiting NCT02206360 - Pancreatic Cancer Early Detection Program

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